Cleared Traditional

K860185 - UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER

K860185 is the FDA 510(k) clearance for UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER by Neuromed, Inc.. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K860185 · Neuromed, Inc. · Neurology device
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Apr 1986
Decision
73d
Days
Class 2
Risk

K860185 is an FDA 510(k) clearance for the UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Neuromed, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neuromed, Inc. devices

Submission Details

510(k) Number K860185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1986
Decision Date April 04, 1986
Days to Decision 73 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 148d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 76
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K860185.
MODEL 3487A PISCES EPIDURAL LEAD
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MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
K873675 · Medtronic Vascular · Oct 1987
MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT
K855107 · Medtronic Vascular · May 1986
CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A
K852827 · Cordis Corp. · Aug 1985
MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL
K844115 · Medtronic Vascular · Feb 1985
MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL
K841584 · Medtronic Vascular · May 1984